Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 3:26 AM
Ignite Modification Date: 2025-12-26 @ 2:06 AM
NCT ID: NCT03395405
Description: None
Frequency Threshold: 5
Time Frame: 180 days
Study: NCT03395405
Study Brief: NNITS-Nitazoxanide for Norovirus in Transplant Patients Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nitazoxanide (500 mg) A single 500 mg tablet of nitazoxanide administered orally twice daily with food for 56 consecutive doses over 28 days. 0 None 0 16 12 16 View
Placebo A single matching placebo tablet administered orally twice daily with food for 56 consecutive doses over 28 days. 2 None 2 15 13 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypoxic Respiratory Failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Uremia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Alanine Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Aspartate Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood Alkaline Phosphatase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood Bilirubin Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood Creatinine Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood Urea Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Haemoglobin Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Platelet Count Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
White Blood Cell Count Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
White Blood Cell Count Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View